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ISO 14971:2019, the current international standard for medical device risk management, provides a systematic approach to identify, analyze, evaluate, and control risks associated with medical devices throughout their entire lifecycle. This standard, which is harmonized according to MDR, outlines the steps that manufacturers must follow to effectively identify, assess and mitigate risks.
To establish an effective risk management process, manufacturers must first identify the Risk Management Team and document a Risk Management Policy as a fundamental driver of the whole process.
The following step is to identify and analyze any potential hazard associated with the device, providing an estimation of each risk, that requires the categorization of the probability of occurrence and the severity of harm(s) that could result from each identified hazardous situation. Then, the acceptability of each risk is evaluated with respect to specific risk acceptability criteria as defined in the policy and, subsequently, risk control measures are implemented to minimize or reduce the identified risks to an acceptable level.
ISO 14971:2019 also highlights the significance of ongoing risk management activities throughout the device's lifecycle to maintain the device on the market. This includes monitoring and reviewing the safety and performance of the device, collecting post-market data, and implementing corrective and preventive actions as necessary in order to continuously guarantee the acceptability of the risk-benefit ratio.
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